DSBS kursus i Clinical Trial Simulation

DSBS har været så heldige, at kunne lokke Ulrika Simonsson fra University of Uppsala (Sverige) til Danmark for at dette kursus også kan blive holdt i Danmark. Det har tidligere været holdt i Sverige.

Clinical Trial Simulation
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Kurset vil finde sted 27- 28 marts 2006
på Hotel Marina A/S, Vedbæk Strandvej 391, 2950 Vedbæk (www.choicehotels.dk)

Pris: 4.000,- for medlemmer, og 5.000,- for ikke-medlemmer.
Det dækker undervisning, materialer, forplejning om dagen, uden overnatning

Deltagerbegrænsning: 25 (NB! Medlemmer har førsteret til kurset)
Tilmelding til: Judith L. Jacobsen e-mail: jlj@statcon.dk tlf: 40 68 28 08
Tilmeldingsfrist: 10. marts 2006

Faktura vil blive tilsendt efter tilmelding, ligesom man også vil modtage en bekræftelse og nærmere information. 

Med venlige hilsner,
DSBS bestyrelsen

Clinical Trial Simulation

27 – 28 Marts 2006

Presenters: Ulrika Simonsson and Judith L. Jacobsen

Ulrika Simonsson, PhD. is Associate Professor at Div of Pharmacokinetics and Drug Therapy, Dept of Pharmaceutical Sciences, Uppsala University, Sweden. Judith L. Jacobsen, PhD. is a senior statistical consultant at Statcon ApS.

In the whitepaper “Innovation or Stagnation: Crisis on the Critical Path to New Medical Products” FDA have presented their concern, that “Despite broad progress in the scientific and technical areas of the drug development process, the development of novel candidate molecular entities into safe and effective new drugs remains a laborious, inefficient, time-consuming and expensive process that has not changed appreciably in decades. To the extent that systemic inadequacies in the drug development process result in excessive risks, costs, and prolongation of safety and efficacy evaluation, society as a whole is adversely affected.” To improve that situation, “Model-based Drug Development” is suggested.

Model-based drug development uses drug and disease models to aggregate and integrate knowledge, over time, for the drug effect(s), disease progression, dose response, relevant covariates and efficacy/safety/toxicity. This model-based approach becomes the basis of clinical trial simulation and leads to improved decision-making in clinical drug development. Clinical trial simulation (CTS), utilizes the computer to simulate virtual patients in the clinical research context, has been applied to better understand possible trial outcomes to optimize clinical study design and clinical planning. This course presents a general framework for Clinical trial Simulation, concerning the planning, conduct and reporting of simulated trials. The course will cover topics like how modeling and simulation can contribute to drug development, simulation in Drug development, good practice and regulatory viewpoints, simulation strategies, planning a CTS project, interpretation of simulation results, different software used in CTS and practical hands-on exercises.

In addition to lectures, there will be discussions based on examples of simulated trials.

During the last session of the course, there will be an opportunity for participants to share their experiences of planning and conducting Clinical trial Simulation and discuss issues that have arisen. Also the issue of the interdisciplinary collaborations needed, when conducting a simulated trial will be discussed with the participants.